Varenicline for the treatment of cocaine dependence: Phase II

描述（由申请人提供）：用于治疗可卡因依赖的伐尼克兰：II期临床试验。可卡因依赖仍然是一个重大的公共卫生问题，即使经过20多年的不懈努力，为治疗可卡因依赖制定有效的行为和药理学干预措施。由于使用可卡因直接造成的健康成本（例如，冠状动脉和血管问题）以及更为间接的健康成本（例如，通过性交易换取毒品而传播艾滋病和丙型肝炎病毒），必须继续努力开发有效的治疗方法。为此，本研究提出了一项双盲安慰剂对照临床试验（n = 200），研究伐尼克兰治疗可卡因依赖，利用应急管理促进治疗出勤率。在最近完成的一项使用相同设计的试点试验（n = 37）中，我们发现随机分配到伐尼克兰的受试者在可卡因使用方面表现出更大的减少，以及他们发现可卡因的价值或强化程度的降低（Plebani等人，修订中审查）。在该研究中，我们使用了可变的强化时间表来提高出勤率。这种强化导致了出勤率的大幅提高，并导致了比通常困扰此类试验的数据缺失少得多。由于这些有希望的结果，我们现在寻求在更大的样本中重复该研究，以便有能力更充分地确定伐尼克兰治疗可卡因依赖的疗效。

DESCRIPTION (provided by applicant): Varenicline for the treatment of cocaine dependence: A phase II clinical trial. Cocaine dependence remains a major public health problem, even after over two decades of steady attempts to develop effective behavioral and pharmacological interventions for treating cocaine dependence. Due to the health costs that come directly from cocaine use (e.g., coronary and vascular problems), and those that are more indirect (e.g., spread of AIDS, HCV from exchanging sex for drugs), it is imperative that efforts to develop efficacious treatments continue. To that end, this is a proposed double-blind placebo-controlled clinical trial (n = 200) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance. In a recently completed pilot trial (n = 37) using the same design, we found that subjects randomized to varenicline showed greater decreases in cocaine use as well as reductions in how valuable or reinforcing they found cocaine (Plebani et al., revision under review). In that study, we used a variable schedule of reinforcement to promote high rates of attendance. That reinforcement led to dramatic increases in attendance rates, and led to far less missing data than usually plagues such trials. Due to these promising results, we now seek to replicate that study in a larger sample in order to have the power to more fully determine the efficacy of varenicline as a treatment for cocaine dependence. PUBLIC HEALTH RELEVANCE: Cocaine dependence is a major public health problem, with few effective treatments, high relapse rates, and a strong association with negative health consequences. As such, research examining potential cocaine dependence medications is needed. Such research should utilize behavioral intervention to maximize treatment attendance and retention in order to better determine medication efficacy, and thus decrease the burden that cocaine dependence places on the healthcare system and on society.